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Find more clinical trials

AHEAD Study: Lecanemab for People With Increased Risk of Alzheimer's Disease

Start: July 13, 2020
End: October 25, 2027
Enrollment: 1400

What Is This Study About?

During the early stages of Alzheimer's disease, amyloid protein forms plaques in the brain. The AHEAD Study is a Phase 3 clinical trial that will test whether the study drug, lecanemab (BAN2401), reduces brain amyloid buildup in people with increased risk of Alzheimer's disease. Study participants will be enrolled in one of two AHEAD trials based on whether they have intermediate or elevated levels of amyloid in their brain. Both trial groups will receive intravenous injections of lecanemab (BAN2401) or a placebo every two weeks for 96 weeks, then every four weeks through 216 weeks. At different points in the study, participants will have a positron emission tomography (PET) brain scan. A PET scan takes pictures of the brain, allowing researchers to see and track changes in the amount of amyloid and tau in a participants brain.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 80 Years

Must have:

General Inclusion Criteria:

  • Participants who are 55 to 64 years of age must have one of the following risk factors for Alzheimer's disease:
    • First degree relative (a parent, brother, sister, or child) diagnosed with dementia before age 75, or
    • Known to have at least one apolipoprotein E4 variant (APOE4) allele, or
    • Known before screening to have elevated brain amyloid according to previous PET, blood test, or cerebrospinal fluid testing
    • Individuals with past amyloid PET scans showing intermediate brain amyloid are eligible to be screened for this study, as long as the participant did not participate in any clinical studies involving anti-amyloid therapies after the PET scan
  • Have not been diagnosed with Alzheimer's disease or another dementia
  • Have elevated or intermediate levels of amyloid in their brains determined by brain imaging as part of the study screening
  • Have a close friend or relative who can serve as a study partner. This person must have weekly contact with the participant by phone, in-person, or email. The study partner must have enough contact such that the study contact believes they can provide meaningful information about the participant's daily function
  • Able to provide written (or electronic, if allowed per country-specific regulations) informed consent and follow all requirements of the study
  • Global Clinical Dementia Rating score of 0
  • Mini-Mental State Examination score greater than or equal to 27 (with educational adjustments)
  • Wechsler Memory Scale-Revised Logical Memory subscale II score of 6

In addition, participants will be assigned to one of two trials based on the following criteria:

A-3 Trial Participants: Meets all of the general inclusion criteria plus the presence of intermediate levels of brain amyloid pathology by amyloid PET scan, defined as approximately 20 to 40 Centiloids on study screening scan

A-45 Trial Participants: Meets all of the general inclusion criteria plus the presence of elevated brain amyloid pathology by amyloid PET scan, defined as approximately greater than (>) 40 Centiloids on study screening scan

Must NOT have:

  • Women who are breastfeeding or pregnant
  • Women of childbearing potential who, within 28 days before study entry, did not use a highly effective method of contraception
  • History of transient ischemic attacks, stroke, or seizures within 12 months of screening
  • Current, or history within the past two years, of psychiatric diagnosis or symptoms that, in the opinion of the study contact, could interfere with study procedures
  • Ineligible for magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, metal implants, or having had other significant abnormal findings on brain MRI
  • Hypersensitivity to any monoclonal antibody treatment
  • Any immunological disease that is not well-managed, or that requires treatment with immunoglobulins, monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis (a process that filters the blood) during the study
  • Bleeding disorder that is not under adequate control (including a platelet count <50,000 or international normalized ratio >1.5) at screening
  • Results of laboratory tests conducted during study screening that are outside the following limits:
    • Thyroid stimulating hormone above normal range
    • Vitamin B12 levels below normal range, unless other tests (homocysteine and methylmalonic acid levels) shows that it is not physiologically significant
  • Positive for HIV
  • Malignant tumor growth within three years of study screening (except for basal or squamous cell carcinoma of the skin or localized prostate cancer in male participants with treatment cycles completed at least six months before screening)
  • Risk of suicide based on responses to the Columbia-Suicide Severity Rating Scale, any suicidal behavior assessment within six months before study screening or the start of the study, or hospitalization or treatment for suicidal behavior in the past five years
  • Known or suspected history of drug or alcohol abuse or dependence within two years before study screening or a positive urine drug test at screening. Participants who test positive for benzodiazepines, opioids, or tetrahydrocannabinol in urine drug testing may not be excluded unless, in the clinical opinion of the investigator, this is due to potential drug abuse
  • Taking any prohibited or illegal medications
  • Participation in another clinical study involving:
    • Any anti-amyloid immunotherapy (example, therapeutic monoclonal antibody or active anti-amyloid vaccine) at any time, unless it can be documented that the participant was randomized to placebo or never received study drug
    • Any immunoglobulin therapy or vaccine within six months before screening unless it can be documented that the participant only received the placebo or never received the study therapy
    • Any experimental drug for Alzheimer's disease within six months before study screening unless it can be documented that the participant received only a placebo or never received the study drug
    • Any other experimental drug or device study in the eight weeks or five half-lives of the drug the time it takes for a drug to be inactive in the body (whichever is longer) before the start of this study unless it can be documented that the participant was in a placebo treatment group
    • Lecanemab
  • Planned surgery which will require general anesthesia to occur during the screening phase of this study or within three months of study group assignment
  • Any other health issues that in the opinion of the study contact will require further medical attention or treatment or may interfere with study procedures or safety
 

Who Is the General Study Contact?

To learn more about participating, call 888-274-2378 or email: esi_medinfo@eisai.com or ahead-participate@usc.edu or visit the AHEAD study website.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Alabama
University of Alabama at Birmingham
Birmingham, AL 35233
Recruiting
Arizona
Banner Alzheimer's Institute
Phoenix, AZ 85006
Recruiting
Banner Sun Health Research Institute
Sun City, AZ 85351
Recruiting
California
University of California, Irvine
Irvine, CA 92697
Recruiting
University of Southern California
Los Angeles, CA 90033
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, CA 92663
Recruiting
Stanford University
Palo Alto, CA 94304
Recruiting
Sharp Neurocognitive Research Center
San Diego, CA 92123
Recruiting
University of California, San Francisco
San Francisco, CA 94158
Recruiting
University of California, Davis
Walnut Creek, CA 94598
Recruiting
Connecticut
Yale University School of Medicine
New Haven, CT 06510
Recruiting
District of Columbia
Howard University
Washington, DC 20060
Recruiting
Georgetown University
Washington, DC 20057
Recruiting
Florida
Brain Matters Research
Delray Beach, FL 33445
Recruiting
Mayo Clinic Jacksonville
Jacksonville, FL 32224
Recruiting
Advanced Clinical Research Network
Miami, FL 33135
Recruiting
Gonzalez MD & Aswad MD Health Sciences
Miami, FL 33125
Recruiting
Wien Center for Clinical Research
Miami Beach, FL 33140
Recruiting
Renstar Medical Research
Ocala, FL 34471
Recruiting
Synexus Clinical Research - Orlando
Orlando, FL 32806
Recruiting
K2 Medical Research, LLC
Orlando , FL 32751
Recruiting
University of South Florida Health - Byrd Alzheimer's Institute
Tampa, FL 33613
Recruiting
Synexus Clinical Research - The Villages
The Villages, FL 32162
Recruiting
Alzheimer's Research and Treatment Center
Wellington, FL 33414
Recruiting
Charter Research
Winter Park, FL 32792
Recruiting
Georgia
Emory University
Atlanta, GA 30329
Recruiting
Columbus Memory Center, LLC
Columbus, GA 31909
Recruiting
Illinois
Northwestern University
Chicago, IL 60611
Recruiting
Rush University Medical Center
Chicago, IL 60612
Recruiting
Indiana
Indiana University School of Medicine
Indianapolis, IN 46202
Recruiting
Kansas
University of Kansas
Fairway, KS 66205
Recruiting
Kentucky
University of Kentucky - Sanders-Brown Center on Aging
Lexington, KY 40504
Recruiting
Maryland
Johns Hopkins University
Baltimore, MD 21224
Recruiting
Massachusetts
Brigham and Women's Hospital Center for Alzheimer's Research and Treatment
Boston, MA 02115
Recruiting
Boston University
Boston, MA 02118
Recruiting
Headlands Eastern MA, LLC
Plymouth, MA 02360
Recruiting
Michigan
University of Michigan
Ann Arbor, MI 48109
Recruiting
Minnesota
Mayo Clinic, Rochester
Rochester, MN 55905
Recruiting
Missouri
Washington University, St. Louis
St. Louis, MO 63108
Recruiting
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas
Las Vegas, NV 89106
Recruiting
New Jersey
Advanced Memory Research Institute of New Jersey
Tom's River, NJ 08755
Recruiting
New York
Columbia University
New York, NY 10032
Recruiting
Mount Sinai School of Medicine
New York, NY 10029
Recruiting
University of Rochester Medical Center
Rochester, NY 14620
Recruiting
North Carolina
Duke Health Center
Durham, NC 27705
Recruiting
AMC Research, LLC
Matthews, NC 28105
Recruiting
Wake Forest University Health Sciences
Winston-Salem, NC 27157
Recruiting
Ohio
Case Western Reserve University
Beachwood, OH 44122
Recruiting
Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland
Cleveland, OH 44195
Recruiting
Ohio State University
Columbus, OH 43210
Recruiting
Oklahoma
Central States Research, LLC
Tulsa, OK 74136
Recruiting
Oregon
Summit Research Network, Oregon
Portland, OR 97210
Recruiting
Oregon Health & Science University
Portland, OR 97239
Recruiting
Pennsylvania
Abington Neurological Associates
Abington, PA 19001
Recruiting
University of Pennsylvania
Philadelphia, PA 19104
Recruiting
University of Pittsburgh
Pittsburgh, PA 15213
Recruiting
Keystone Clinical Studies, LLC
Plymouth Meeting, PA 19462
Recruiting
Rhode Island
Butler Hospital
Providence, RI 02906
Recruiting
Rhode Island Hospital
Providence, RI 02903
Recruiting
South Carolina
Ralph H. Johnson VA Health Care System
Charleston, SC 29403
Recruiting
Tennessee
Vanderbilt University Medical Center
Nashville, TN 37212
Recruiting
Texas
UT Southwestern, Dallas
Dallas, TX 75390
Recruiting
University of North Texas Health Sciences Center
Fort Worth, TX 76107
Recruiting
Houston Methodist Neurological Institute
Houston, TX 77030
Recruiting
Baylor College of Medicine
Houston, TX 77030
Recruiting
University of Texas Health Sciences Center of San Antonio
San Antonio, TX 78229
Recruiting
Virginia
Eastern Virginia Medical School
Norfolk, VA 23510
Recruiting
National Clinical Research, Inc.
Richmond, VA 23294
Recruiting
Washington
University of Washington, Alzheimer’s Disease Research Center
Seattle, WA 98104
Recruiting
VA Puget Sound/Seattle Institute for Biomedical and Clinical Research
Seattle, WA 98108
Recruiting
Wisconsin
University of Wisconsin - Madison Hospital and Health Clinic
Madison, WI 53792
Recruiting

Who Sponsors This Study?

Lead: Eisai Inc.

Collaborator Sponsor

  • Alzheimer’s Clinical Trial Consortium (ACTC)
  • Biogen
  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT04468659

 

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An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health